# FDA recall D-1306-2022

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2022-06-29.

## Product

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.

## Reason for recall

Defective Container: Recall of these batches has been initiated due to complaints of  difficult to open blister and tablet breaks while opening the blister .

## Distribution

nationwide

## Key facts

- **Recall number:** D-1306-2022
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-29
- **Report date:** 2022-08-17
- **Termination date:** 2024-06-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1306-2022

## Citation

> AI Analytics. FDA recall D-1306-2022. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1306-2022. Source: US FDA. Licensed CC0.

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